N/A
N=6,617
Observational Data Analysis in EuroSIDA (MK-0518-058)
HIV-1 Infections
Bottom Line
View on ClinicalTrials.gov: NCT01078233 ↗Enrolled (actual)
6,617
Serious AEs
—
Results posted
Sep 2015
Primary outcome: Primary: Incidence of Malignancy — 1.29; 1.17; 0.81 Events per 100 person-years of follow-up
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Malignancy |
1.29; 1.17; 0.81 | — |
| PRIMARY Incidence of Clinically Important Hepatic Events |
0.11; 0.90; 0.28 | — |
| PRIMARY Incidence of Lipodystrophy |
0.15; 1.04; 0.64 | — |
| PRIMARY Incidence of All-Cause Mortality |
0.86; 1.27; 0.68 | — |
Summary
The main objective of the study is to monitor health outcomes associated with antiretroviral drugs in a population of HIV-infected patients.
Eligibility Criteria
Inclusion Criteria
- Adults 16 years old and older with HIV-1
Exclusion Criteria
- Subjects will be excluded if they have no prospective follow up
Data sourced from ClinicalTrials.gov (NCT01078233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.